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Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

NCT06280950 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.

Conditions

  • Liver Transplant

Interventions

DRUG

Everolimus

* The first step is the addition of everolimus to participants in this group pre-randomization. * Participants on a mycophenolate compound will stop taking it within 7 days of initiating everolimus, either by immediate discontinuation or a 7-day taper. * Participants taking prednisone will taper off prednisone by 6 months post-transplant. * The second step is tacrolimus minimization and withdrawal to everolimus monotherapy in this group after randomization.

DRUG

Tacrolimus (continued reduction)

* Participants randomized in this cohort will have their tacrolimus dose reduced by 50% following randomization. * They will maintain this daily dose for 4 weeks/1 month (28-30 days). Tacrolimus withdrawal will occur in intervals of 30 days or 4 weeks. * Each subsequent reduction will be based on LFT stability over the prior time interval before the next reduction

DRUG

Tacrolimus (maintain 50% reduction)

\- Participants randomized in this cohort maintain initial reduced dose of Tacrolimus and everolimus for study duration.

DRUG

Everolimus

* The first step is the addition of everolimus to participants in the interventional group pre-randomization. * Participants on a mycophenolate compound will stop taking it within 7 days of initiating everolimus, either by immediate discontinuation or a 7-day taper. * Participants taking prednisone will taper off prednisone by 6 months post-transplant. * The second step is to continue on the reduced tacrolimus and everolimus regimen.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Justin Boike, MD · Northwestern University Feinberg School of Medicine: Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-12
Primary Completion
2028-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280950 on ClinicalTrials.gov